NCT00565838

Brief Summary

The objective of the study was to evaluate the impact AFS and TVT procedures on quality-of-life in incontinent women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
Last Updated

November 30, 2007

Status Verified

November 1, 2007

First QC Date

November 28, 2007

Last Update Submit

November 28, 2007

Conditions

Stress Urinary Incontinence

Keywords

Randomized studysurgical treatmentautologous fascial slingTVTstress urinary incontinence.

Outcome Measures

Primary Outcomes (1)

  • Primary outcome

    Observational

Study Arms (1)

2

G1 - Autologous Fascial Sling G2 - TVT

Procedure: AFS and TVT

Interventions

AFS and TVTPROCEDURE

Autologous Fascial Sling and Tension- Free Vaginal Tape

Also known as: AFS, TVT
2

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample

You may qualify if:

  • Stress Urinary Incontinence

You may not qualify if:

  • Detrusor obstruction or hyperactivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School of Medicine

Botucatu, São Paulo, 18618-970, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • João L Amaro, PhD MD

    Department of Urology - UNESP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 30, 2007

Study Start

January 1, 2001

Study Completion

November 1, 2007

Last Updated

November 30, 2007

Record last verified: 2007-11

Locations

BR(1)